510(k) K250741

Evidence MultiSTAT DOA Urine MultiPlex by Randox Laboratories Limited — Product Code DJG

K250741 is an FDA 510(k) premarket notification submitted by Randox Laboratories Limited for the device "Evidence MultiSTAT DOA Urine MultiPlex". The FDA issued a decision of Substantially Equivalent on January 23, 2026. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650. Randox Laboratories Limited has at least 10 other 510(k) clearances on record.